Phase 1B Study of Atezolizumab and Bevacizumab Combined With Stereotactic Body Radiation Therapy for Treating Unresectable Liver Cancer Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the safety and tolerability of a combination of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy SBRT for people with unresectable hepatocellular carcinoma, a type of liver cancer that cannot be removed by surgery. This phase 1B study aims to understand how these treatments work together to treat and limit recurrence of this cancer. The FDA has approved atezolizumab and bevacizumab for this cancer, but not the combination including radiation therapy. Participants will receive atezolizumab and bevacizumab through intravenous infusions along with SBRT, a form of external beam radiation therapy. The study starts with a safety lead-in phase involving 6 participants to find the maximum tolerated dose of SBRT combined with the drugs, lasting 18 weeks with cycles every 3 weeks. Following this, up to 14 more participants will join the expanded study phase, continuing the drug infusions every 3 weeks with SBRT given in the first cycle. During the study, participants will undergo evaluations and follow-up visits including imaging and laboratory tests to monitor tumor response and side effects. Researchers will measure dose limiting toxicities, progression-free survival, overall survival, and changes in liver function over up to 5 years. Participants may stay in the study as long as treatments are safe and helpful, with long-term follow-up to assess outcomes and safety. The study is supported by Genentech and led by Massachusetts General Hospital.

Atezolizumab+Bevacizumab+SBRT in Unresectable HCC